# K130176: Firebird Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Orthofix
- Decided: Mar 28, 2013 after 62 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K980447 (1998). 67 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122901: Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System, Orthofix (2012) Summary page 2.

## Most influential descendants
- K173180: Mega Plus Spine System (2018), 3 descendants of its own
- K183080: Mega Plus Spine System (2018), 2 descendants of its own
- K240963: Spinal System (2024), 0 descendants of its own
- K200981: Mega Plus MIS Spine System (2020), 0 descendants of its own
- K191655: MEGAFIX® Pedicle Screw Spinal System (2020), 0 descendants of its own

## Indications for use
The Firebird Fixation System is intended for posterior, non-cervical pedicle fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications: a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) b) spondylolisthesis, c) trauma (i.e., fracture or dislocation), d) spinal stenosis, e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), f) tumor, g) pseudoarthrosis, and h) failed previous fusion The Firebird Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors. The Phoenix MIS Spinal Fixation System when used with the Firebird Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

Source page: https://510kreport.com/device/K130176
Methodology: https://510kreport.com/methodology